DECA DURABOLIN - PACKAGE LEAFLET - LEAFLETS

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Deca Durabolin - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Nandrolone

Deca-Durabolin 25 mg / 1 ml solution for injection for intramuscular use

Why is Deca Durabolin used? What is it for?

Deca-Durabolin contains the active ingredient nandrolone decanoate which belongs to a class of hormone-based medicines called 'anabolic steroids'.

Deca-Durabolin is used as a supportive treatment for bones that have become thin and brittle (osteoporosis) in old age or as a result of medical treatments (iatrogenic causes).

Contraindications When Deca Durabolin should not be used

Do not take Deca Durabolin

if you are allergic to the active substance or any of the other ingredients of this medicine
if you are allergic to peanuts or soy (see "Deca-Durabolin contains peanut oil and benzyl alcohol")
if you are pregnant or breastfeeding (see "Pregnancy, breastfeeding and fertility")
if you have liver problems (liver failure, a condition in which the liver cannot perform its functions) (see "Warnings and precautions")
if you have prostate cancer (prostate cancer and adenoma)
if you are a man with breast cancer (breast cancer)
if you have ever had cancer that started in the liver (primary liver cancer)
if you have high levels of calcium in your urine and blood for a long time (consolidated hypercalciuria and hypercalcemia)
if you are not yet sexually developed (prepubertal age or age before the onset of puberty)
if you have kidney problems (nephrotic syndrome, a disease involving the loss of protein in the urine)

The medicine contains benzyl alcohol so it should not be given to children under the age of three (see "Deca-Durabolin contains peanut oil and benzyl alcohol").

Precautions for use What you need to know before taking Deca Durabolin

Talk to your doctor, pharmacist or nurse before taking Deca-Durabolin.

Your doctor may ask you to have blood or prostate tests before the start of treatment, every three months for the first 12 months and thereafter.

Take special care if any of the following occur:

If you notice any signs of masculinization (for example, lowering of the voice or growth of facial hair).
If, following treatment with Deca-Durabolin, you suspect an increase in the size of a gland in men called the prostate. In this case, your doctor will have you carry out some follow-up tests, especially if you are elderly.
If you are elderly, and have elevated blood calcium levels (hypercalcaemia) and / or conditions that lead to elevated blood calcium levels such as kidney injury (nephropathy), prostate cancer (prostate cancer and adenoma), breast cancer (male breast cancer), other cancers and the spread (metastasis) of cancer to the skeleton (see "Do not take Deca-Durabolin"). Elevated calcium values can also occur during treatment with Deca-Durabolin.
If you have other diseases already present such as heart, kidney and liver problems (heart, kidney or liver failure / disease) treatment with Deca-Durabolin can cause complications characterized by fluid collection in the body with or without heart problems (edema with or without congestive heart failure). In these cases the treatment must be stopped immediately.
If you have had a heart attack, problems with your heart, liver, kidneys (heart, liver or kidney failure), increased blood pressure (hypertension), epilepsy or headache, you will be checked by your doctor because of the risk of worsening or relapse of the disease (relapse). In these cases the treatment must be stopped immediately.
If you have diabetes mellitus, Deca-Durabolin can improve sugar tolerance (see "Other medicines and Deca-Durabolin") and the need for insulin or other antidiabetic medicines can be reduced.
If you are being treated with medicines that thin the blood (coumarin-type anticoagulants), Deca-Durabolin may enhance their action (see "Other medicines and Deca-Durabolin").
If you are a woman with breast cancer that has spread to the bone (breast cancer and skeletal metastases) your doctor will check your blood and urine calcium regularly. If there is an increase in calcium values in the blood or urine (hypercalcaemia or hypercalciuria) the treatment should be stopped.
If you have impaired heart or kidney function, increased blood pressure or epilepsy you will be closely monitored by your doctor, as Deca-Durabolin can cause water retention (fluid retention).

For those who carry out sports activities

The use of Deca-Durabolin without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.

Misuse of this medicine to improve sports ability carries serious health risks and should be discouraged.

Patients participating in competitions regulated by the World Anti-Doping Agency (WADA) should consult the WADA code before using this medicine as Deca-Durabolin can interfere with doping tests.

Children and adolescents

The drug is contraindicated under 3 years and in general in patients not yet sexually developed (prepubertal age).

Interactions Which drugs or foods can modify the effect of Deca Durabolin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Other medicines may affect the effects of Deca-Durabolin or Deca-Durabolin may affect the effects of other medicines. Therefore, you should tell your doctor or pharmacist if you are taking or about to take:

Insulin and / or other medicines to control blood sugar levels;
Erythropoietin (a medicine to reduce anemia);
Anticoagulants (medicines to thin the blood).

The use of Deca-Durabolin may lead to a reduction in the doses of these medicines. Also tell your doctor or pharmacist if you are taking or about to take:

the ACTH hormone or corticosteroids (used to treat various conditions, such as rheumatism, arthritis, allergic conditions and asthma).

Administration of Deca-Durabolin can increase the risk of water retention, especially if the heart and liver are not functioning properly.

Deca-Durabolin can also affect the results of some laboratory tests (for example those of the thyroid gland). Therefore, you should tell your doctor or the laboratory staff performing the tests that you are using this medicine.

Warnings It is important to know that:

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy: Deca-Durabolin should not be used during pregnancy. Deca-Durabolin treatment should be stopped if you are pregnant (see "Do not take Deca-Durabolin").

Breastfeeding: Deca-Durabolin should not be used while breastfeeding (see "Do not take DecaDurabolin").

Fertility: In men, treatment with Deca-Durabolin can lead to fertility disorders by suppressing sperm formation. In women, treatment with Deca-Durabolin can lead to a reduction in the frequency or suppression of the menstrual cycle.

Driving and using machines

Deca-Durabolin has no or negligible influence on the ability to drive or use machines.

Deca-Durabolin contains peanut oil and benzyl alcohol

Do not use Deca-Durabolin if you are allergic to peanuts or soy (see "Do not take DecaDurabolin").

Deca-Durabolin should not be given to children under three years of age as it contains benzyl alcohol (100 mg per ml of solution) which can cause toxic and allergic reactions.

Dosage and method of use How to use Deca Durabolin: Dosage

Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.

Deca-Durabolin must be given as an "injection" into a muscle (intramuscular).

The recommended dose is:

one 25 mg injection every 3 weeks;
in severe cases, 50 mg every 3 weeks can be administered to be practiced deeply intramuscularly.

The duration of treatment depends on the clinical response and the possible occurrence of undesirable effects.

Use in children and adolescents

The drug is contraindicated in subjects not yet sexually developed (prepubertal age).

Overdose What to do if you have taken an overdose of Deca Durabolin

In case of accidental administration of an overdose of Deca-Durabolin, notify your doctor immediately or go to the nearest hospital.

If you have the impression that the effect of this medicine is too strong, tell your doctor or nurse immediately.

Side Effects What are the side effects of Deca Durabolin

If you forget to take Deca Durabolin

If you have forgotten a scheduled injection, tell your doctor or nurse as soon as possible. Do not take a double dose to make up for a forgotten dose.

If you stop taking Deca Durabolin

The effects of Deca-Durabolin do not disappear immediately after stopping, but gradually diminish.

When treatment with Deca Durabolin is stopped, the disorders that occurred before treatment may return within a few weeks.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects may not go away quickly with Deca-Durabolin discontinuation, due to its class. Injectable solutions can usually cause a local reaction at the injection site.

Depending on the dose, frequency and total period of administration of Deca-Durabolin the following side effects may occur:

masculinization (virilism)
increased fat in the blood (hyperlipidaemia and hypertriglyceridemia)
reduced tolerance to sugars (carbohydrates)
increased sex drive (libido)
increased blood pressure
voice disturbances (dysphonia)
nausea
liver problems (abnormal liver function and liver peliosis, a disease characterized by blood-filled cavities distributed throughout the liver)
boils (acne)
rash
itch
abnormal hair growth (hirsutism)
growth restriction (premature sealing of the epiphyses)
reduction in the amount of urine
benign enlargement of the prostate (benign prostatic hyperplasia)
persistent and abnormal penile erection (priapism)
increase in the volume of the penis
increase in the volume of the clitoris
altered rhythm of the menstrual cycle (oligomenorrhea)
absence of menstruation (amenorrhea)
decrease in sperm count
collection of fluids in the body (edema)
injection site reactions
severe sudden allergic reactions (anaphylactic and hypersensitivity reactions)
decrease in "good" cholesterol (high density lipoprotein or HDL cholesterol)
increase in a blood component (hemoglobin).

Additional side effects in children and adolescents

The following side effects have been reported in pre-sexual (prepubescent) children using Deca-Durabolin:

early sexual development
increased frequency of erections
penis enlargement
growth restriction.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.it. / it / responsible.

By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

Store below 30 ° C.

Do not refrigerate or freeze. Store in the original package and keep the container in the outer carton.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Other Information

What Deca-Durabolin contains

The active ingredient is nandrolone decanoate. A 1ml vial contains 25mg of nandrolone decanoate.
The other ingredients are benzyl alcohol and peanut oil.

Description of what Deca-Durabolin looks like and contents of the pack

Solution for injection for intramuscular use.

Pack of 1 glass vial of 1 ml.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

More information on Deca Durabolin can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

DECA-DURABOLIN 25 MG / 1 ML INJECTABLE SOLUTION FOR INTRAMUSCULAR USE

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

One vial of Deca-Durabolin 25 mg / 1 ml contains:

Active principle:

nandrolone decanoate 25 mg.

Excipients with known effects:

benzyl alcohol, peanut oil.

For the full list of excipients see section 6.1.

03.0 PHARMACEUTICAL FORM

Solution for injection for intramuscular use. Clear, oily, yellow solution.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Supportive treatment of senile or iatrogenic osteoporosis.

04.2 Posology and method of administration

Dosage

Adults

In general, a 25 mg injection every 3 weeks; in severe cases, 50 mg can be administered every 3 weeks to be practiced deeply intramuscularly.

The duration of treatment depends on the clinical response and the possible occurrence of side effects.

Pediatric population

Safety and efficacy in children have not yet been established.

Method of administration:

Deca-Durabolin should be administered by deep intramuscular injection.

04.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, including peanut oil. Deca-Durabolin is therefore contraindicated in patients allergic to peanut or soya (see section 4.4).

The medicinal product contains benzyl alcohol therefore it should not be given to children under 3 years of age (see section 4.4).

Pregnancy and lactation (see section 4.6).

Hepatic failure, prostate cancer and adenoma, male breast cancer, history of primary liver cancer, established hypercalciuria and hypercalcaemia (see section 4.4).

Pre-pubertal subjects.

Nephrotic syndrome (see section 4.4).

04.4 Special warnings and appropriate precautions for use

The preparation, if administered in high doses and for a long time, can exert androgenic action.

In women with breast cancer and skeletal metastases, serum and urinary calcium values should be determined regularly; if hypercalcaemia or hypercalciuria occurs, treatment should be discontinued.

Patients with myocardial or renal dysfunction, hypertension or epilepsy should be followed carefully as nandrolone decanoate, like other medicines in this category, can cause water retention.

Hepatopathic subjects must be monitored. In diabetics, the need for insulin or other hypoglycaemic medicines may be reduced.

Medical examination:

Physicians should consider monitoring patients to be treated with Deca-Durabolin prior to the start of treatment, every three months for the first 12 months, and then annually thereafter with observation of the following parameters:

• digital rectal examination (EDR) of the prostate and determination of the PSA value to exclude benign prostatic hypertrophy or subclinical prostate cancer (see section 4.3)

• hematocrit and hemoglobin to exclude polycythemia.

Conditions that need supervision:

Patients, especially the elderly, with the following conditions should be monitored for:

• hypercalcaemia and / or conditions leading to hypercalcaemia such as nephropathies, prostate and breast cancer, other cancers and skeletal metastases (see section 4.3). Hypercalcaemia can also occur during treatment with anabolic steroids. Hypercalcemia must first be treated appropriately and, after normal calcium levels have been restored, hormone therapy can be resumed.

• Comorbid conditions - In patients with pre-existing heart, kidney or liver failure / disease, treatment with anabolic steroids may cause complications characterized by edema with or without congestive heart failure. In such cases, treatment should be stopped immediately.

Patients who have had myocardial infarction, heart, liver or kidney failure, hypertension, epilepsy or migraine should be monitored for the risk of worsening or recurrence. In such cases, treatment should be stopped immediately.

• Diabetes mellitus - Deca-Durabolin may improve glucose tolerance in diabetic patients (see section 4.5).

• Anticoagulant therapy - Deca-Durabolin may potentiate the anticoagulant action of coumarin-type agents (see section 4.5).

Adverse events:

If adverse reactions associated with the use of anabolic steroids occur (see section 4.8), the treatment with Deca-Durabolin should be discontinued and, upon resolution of the disorder, it should be resumed at a lower dose.

Virilization:

Patients should be informed of the potential for signs of virilization. In particular singers and women who carry out professions in which the word is used, must be informed about the risk of deepening the timbre of the voice. If signs of virilization occur, the risk / benefit ratio should be re-analyzed with the individual patient.

(Improper) use in sport:

Patients participating in competitions regulated by the World Anti-Doping Agency (WADA) must consult the WADA code before using this medicine as Deca-Durabolin can interfere with doping tests. The misuse of anabolic steroids to improve ability in sports involves serious health risks and should be discouraged.

Important information about some of the excipients:

Deca-Durabolin contains peanut oil. Refined peanut oil may contain peanut proteins. The monograph of the European Pharmacopoeia does not provide for an assay for residual proteins.

Deca-Durabolin contains 100 mg of benzyl alcohol per ml of solution and should not be given to premature babies or newborns. Benzyl alcohol can cause toxic and anaphylactic reactions in children up to 3 years of age.

04.5 Interactions with other medicinal products and other forms of interaction

Enzyme inducers can reduce nandrolone levels, while enzyme inhibitors can increase them, therefore Deca-Durabolin dose adjustment may be required.

Insulin and other antidiabetic medicines:

Anabolic steroids may improve glucose tolerance and reduce the need for insulin or other antidiabetic medicinal products in diabetic patients (see section 4.4). Patients with diabetes mellitus should therefore be monitored especially at the start or end of treatment and at periodic intervals during treatment with Deca-Durabolin.

Anticoagulant therapy:

High doses of Deca-Durabolin may potentiate the anticoagulant action of coumarin-type agents (see section 4.4). Therefore, close monitoring of prothrombin time and, if necessary, dose reduction of anticoagulants is necessary during therapy.

ACTH or corticosteroids:

Concomitant administration of anabolic steroids and ACTH or corticosteroids may increase edema formation; therefore the combination of these active substances should be done with caution, especially in patients with cardiac or hepatic disease or in patients predisposed to edema (see section 4.4).

Interactions with laboratory tests:

Anabolic steroids can reduce thyroxine binding globulin levels resulting in a reduction in total serum T4 levels and an increase in resin uptake of T3 and T4. However, free thyroid hormone levels remain unchanged and there is no clinical evidence of thyroid dysfunction.

Recombinant human erythropoietin:

The combination of Deca-Durabolin (50-100 mg / week) with recombinant human erythropoietin (rhEPO), especially in women, may allow a reduction in the dose of erythropoietin to reduce anemia.

No interactions with food have been reported so far.

04.6 Pregnancy and breastfeeding

Fertility:

In men, treatment with Deca-Durabolin can lead to fertility disorders by suppressing sperm formation. In women, treatment with Deca Durabolin may lead to a reduction in the frequency or suppression of the menstrual cycle (see section 4.8).

Pregnancy:

There are no adequate data on the use of Deca-Durabolin in pregnant women. In view of the risk of virilization of the fetus, Deca-Durabolin should not be used during pregnancy (see section 4.3). Treatment with Deca-Durabolin should be interrupted in case of pregnancy.

Feeding time:

There are no adequate data on the use of Deca-Durabolin during breastfeeding. Therefore, Deca-Durabolin should not be used during lactation (see section 4.3).

04.7 Effects on ability to drive and use machines

Deca-Durabolin has no or negligible influence on the ability to drive or use machines.

04.8 Undesirable effects

Due to the nature of Deca-Durabolin, side effects cannot disappear quickly with discontinuation of the medicine. Injectable solutions can usually cause a local reaction at the injection site.

Depending on the dose, frequency and total period of administration of Deca-Durabolin the following undesirable effects may occur (see also section 4.4):

System and organ classification MedDRA Terminology * Endocrine pathologies Virilism Metabolism and nutrition disorders Hyperlipidemia, Reduced tolerance to carbohydrates Psychiatric disorders Increased libido Vascular pathologies Hypertension Respiratory, thoracic and mediastinal disorders Dysphonia Gastrointestinal disorders Nausea Hepatobiliary disorders Abnormal liver function, Peliosis liver Skin and subcutaneous tissue disorders Acne, Rash, Itching, Hirsutism Musculoskeletal and connective tissue disorders Premature sealing of the epiphyses Renal and urinary disorders Reduction in urinary flow Diseases of the reproductive system and breast Benign prostatic hyperplasia, Priapism, Penis enlargement, Clitoral enlargement, Oligomenorrhea, Amenorrhea, Decreased sperm count General disorders and administration site conditions Edema, Injection site reaction Anaphylactic and hypersensitivity reactions Diagnostic tests Decrease in high-density lipoprotein, Increase in triglycerides, Increase in hemoglobin Injury, poisoning and procedural complications Intentional misuse

* MedDRA version 15.0.

Pediatric population:

The following undesirable effects have been reported in prepubertal children using androgens: early sexual development, increased frequency of erections, penile enlargement and premature sealing of the epiphyses.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address:" www.agenziafarmaco.gov.it/it/responsabili ".

04.9 Overdose

The acute toxicity of nandrolone decanoate in animals is very low. There have been no reports of acute overdose with Deca Durabolin in humans.

Chronic overdose to increase athletic ability carries serious health risks for those who abuse it.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: anabolic steroids, derivatives of estrene.

ATC code: A14A B01.

Deca-Durabolin contains the decanoate ester of nandrolone. This decanoate ester gives the preparation a duration of action of approximately three weeks after injection. In circulation, the decanoate ester is hydrolyzed to nandrolone. Nandrolone is chemically related to the male hormone testosterone. It has been shown that Deca-Durabolin has a positive action on the metabolism of calcium, of which it favors intestinal absorption. At the level of bone tissue, nandrolone decanoate stimulates the formation of the bone matrix and promotes mineralization; clinically these effects are demonstrated by a positive nitrogen balance, an increase in the circulating fraction of radio-calcium after oral administration of 47Ca and an increase in bone mineral content.

In animals, nandrolone decanoate has a stimulating effect on erythropoiesis probably by directly stimulating hematopoietic stem cells in the bone marrow and increasing the release of erythropoietin.

05.2 Pharmacokinetic properties

Absorption

Nandrolone decanoate injected i.m. it is absorbed slowly (half-life about 5-15 days). By the intervention of plasma esterases, the therapeutically active substance, nandrolone, is released from the ester bond slowly and steadily but at a different rate depending on the animal species; in humans, the therapeutic effect is maintained for at least 3 weeks.

Distribution

In the blood, the ester is rapidly hydrolyzed to nandrolone with a half-life equal to or less than one hour. The combined process of hydrolysis, distribution and elimination of nandrolone has an average half-life of approximately 4 hours.

Biotransformation and excretion

Nandrolone is metabolized in the liver. The biotransformation then proceeds through the enzymatic oxidation of the 17 -? - hydroxy group to 17-keto; the elimination of the 17-keto-steroids finally takes place via the urine.

05.3 Preclinical safety data

In rat and mouse studies, nandrolone decanoate showed low toxicity. After subcutaneous and intraperitoneal administration the maximum tolerated dose is greater than 2 g / kg. Total weekly doses up to 25 mg / kg, administered for 4 months in the rat and for 6 months in the dog, do not cause toxic effects. In addition, no teratogenic effects were found in rats following administration of 0.5 mg / kg / day of nandrolone decanoate from day 10 to day 20 of pregnancy.

No formal studies have been conducted to evaluate reproductive toxicity, genotoxicity and carcinogenicity. As a class, anabolic steroids are believed to be likely to be carcinogenic to humans (IARC Group 2a).

The use of androgens in different species has resulted in virilization of the external genitalia of female fetuses. In some publications it has been reported that nandrolone is genotoxic in the micronucleus test. in vitro and in the mouse micronucleus test but not in the rat and the mouse and rat comet test.